Supporting Treatment Access and Recovery Through Linkage and Support

Substance Use Disorders Clinical Trial

— STAR-LS  

Official title:

Rigorous Evaluation of Strategies to Prevent Overdose Through Linking People With Illicit Substance Use Disorder to Recovery Support Services

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05713695
• Other study ID #: STUDY00000749
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: September 2025

Study information

• Verified date: May 2023
• Source: University of Massachusetts, Worcester
• Contact: David Smelson, PsyD
• Phone: 508-713-5420
• Email: David.Smelson[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This 3-year Hybrid Type 1 study will randomize 208 people with co-occurring substance use and mental health disorders (COD) referred from the Worcester Hub. This study seeks to evaluate the effectiveness of MISSION, a multi-component team approach, versus linkage with a Peer Specialist on improving outcomes among individuals with CODs. We expect that individuals receiving MISSION versus linkage only will show greater improvement in treatment engagement, substance use, and mental health outcomes. This study will also concurrently conduct a process evaluation to inform sustainability and future implementation of such interventions.

Description:

Addiction is a growing public health problem in the United States (U.S.), with nearly 21 million Americans meeting criteria for substance use disorder (SUD), 1.6 million meeting criteria for opioid use disorder (OUD), and opioid-related overdoses have increased by 50% over the past 5 years. Among people with SUD, 49% have comorbid mental health disorders (COD). Individuals with COD are vulnerable to substance use relapses, mental illness exacerbations, overdoses, homelessness, and criminal justice involvement. However, despite the high rates of morbidity, mortality, and broad social determinant of health needs among people with COD, only 8% of individuals in the U.S. received treatment for both mental illness and SUD. Among those with a COD receiving treatment, 6-month engagement rates are as low as 16% for psychosocial treatments, and 90% of individuals leaving treatment will relapse within 12 weeks. Massachusetts is also hard hit, with a 16% higher SUD prevalence compared to the U.S., and Worcester, the second largest city in Massachusetts, is disproportionately affected by SUD, having one of the highest overdose rates in the state and is ranked 2nd on the Center for Disease Control and Prevention's social vulnerability index. These findings highlight the need to improve treatment access and engagement to support recovery in Worcester, Massachusetts. Both linkage and multicomponent wraparound models have gained popularity as a solution to increase treatment access and engagement. Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking (MISSION) is a hybrid multicomponent linkage and treatment approach, providing assertive outreach linkage support combined with psychosocial treatment, delivered by a cross disciplinary team. MISSION is aligned with the Social Ecological Model (SEM) to address multilevel client needs via 3 evidence-based practices. They include 1) Critical Time Intervention (CTI), a time-limited form of assertive community treatment; 2) Dual Recovery Therapy (DRT), which is integrated group therapy for COD; and 3) Peer Support (PS), offering support for people in recovery by people in recovery. In response to Funding Opportunity Announcement (RFA-CE-22-010), the proposed 3-year Hybrid Type I study, "Supporting Treatment Access and Recovery through Linkage and Support (STAR-LS)," will recruit and randomize 208 patients with COD in Worcester, MA in the Hub, a program run by the Worcester Health and Human Services to one of the following conditions: 1) MISSION; or 2) Peer Support (linkage only). There are three specific aims: Aim 1: To evaluate the effectiveness of MISSION or compared to Peer Support to improve engagement, substance use and mental health symptoms. Aim 2: To examine mechanisms of action of the interventions. Aim 3: To conduct a sequential mixed methods process evaluation to inform sustainability and future implementation. This proposal is aligned with CDC's Strategic Priority Areas and Health People 2030 Core Objectives as it intends to improve behavioral health outcomes strengthen and sustain the recovery ecosystem for people with COD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: September 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Are 18 or older;
• Have a COD (1 or more substance use disorders (e.g., alcohol and illicit substances), and a mental health disorder (including depression, anxiety, trauma related disorders, bipolar, and/or schizophrenia);
• Are in the Hub; and
• Are not engaged in other ongoing multi-component treatment for COD with a behavioral health treatment provider or have not seen their provider for at least 3 months.

Exclusion Criteria:

• We will exclude individuals who are acutely psychotic, acutely suicidal with a plan, or homicidal
• Or with concurrent severe alcohol use disorder or high dose benzodiazepine requiring detoxification.

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Mental Health Disorders
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Full MISSION
MISSION is a time-limited, cross disciplinary, team-based wraparound approach that provides 6 months of psychosocial treatment combined with assertive outreach, empowering clients to access and engage in care and community services to promote recovery. The MISSION treatment curriculum integrates 3 evidence-based practices: 1) Critical Time Intervention (CTI), a time-limited form of assertive community treatment; 2) Dual Recovery Therapy (DRT), which is integrated mental health and substance use group therapy; and 3) Peer Support (PS), offering support for people in recovery by people in recovery.
• Linkage Only Delivered by a Peer Specialist
Linkage only is provided via Peer Specialists whom have lived experiences similar to that of our participants. Linkage only includes informal treatment planning and linkages and supports to needed community services.

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	Centers for Disease Control and Prevention, University of Massachusetts, Amherst, University of Massachusetts, Lowell

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-report opioid use and other substance use	Measured by self-report days of use using the Time-line Follow Back (TLFB)	Baseline
Primary	Self-report opioid use and other substance use	Measured by self-report days of use using the Time-line Follow Back (TLFB)	3-months
Primary	Self-report opioid use and other substance use	Measured by self-report days of use using the Time-line Follow Back (TLFB)	6-months
Primary	Self-report opioid use and other substance use	Measured by self-report days of use using the Time-line Follow Back (TLFB)	9-months
Primary	Mental Health Functioning	Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)	Baseline
Primary	Mental Health Functioning	Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)	3-months
Primary	Mental Health Functioning	Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)	6-months
Primary	Mental Health Functioning	Measured by self-report mental health symptoms on Behavior and Symptom Identification Scale (BASIS-24)	9-months
Primary	PTSD Symptoms	Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)	Baseline
Primary	PTSD Symptoms	Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)	3-months
Primary	PTSD Symptoms	Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)	6-months
Primary	PTSD Symptoms	Measured by self-report PTSD symptoms on Patient Checklist (PCL-5)	9-months
Primary	Mental Health Impairment	Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)	Baseline
Primary	Mental Health Impairment	Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)	3-months
Primary	Mental Health Impairment	Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)	6-months
Primary	Mental Health Impairment	Measured by self-report on World Health Organization Disability Assessment (WHODAS 2.0)	9-months
Primary	Psychiatric Severity	Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)	Screening
Primary	Psychiatric Severity	Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)	Baseline
Primary	Psychiatric Severity	Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)	3-months
Primary	Psychiatric Severity	Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)	6-months
Primary	Psychiatric Severity	Measured by Structured Clinical Interview for Diagnostic Statistical Manual (DSM)-5 (SCID-RV)	9-months
Primary	Health functioning	Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)	Baseline
Primary	Health functioning	Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)	3-months
Primary	Health functioning	Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)	6-months
Primary	Health functioning	Measured by the World Health Organization Quality of Life Scale Brief Version (WHOQOL-BREF)	9-months
Primary	Therapeutic Alliance Client	Measured by Working Alliance Inventory-C	Baseline
Primary	Therapeutic Alliance Client	Measured by Working Alliance Inventory-C	3-months
Primary	Therapeutic Alliance Client	Measured by Working Alliance Inventory-C	6-months
Primary	Therapeutic Alliance Client	Measured by Working Alliance Inventory-C	9-months
Primary	Therapeutic Alliance Therapist	Measured by Working Alliance Inventory-T	Baseline
Primary	Therapeutic Alliance Therapist	Measured by Working Alliance Inventory-T	3-months
Primary	Therapeutic Alliance Therapist	Measured by Working Alliance Inventory-T	6-months
Primary	Therapeutic Alliance Therapist	Measured by Working Alliance Inventory-T	9-months
Primary	Recovery Capital	Measured by Assessment of Recovery Capital (ARC)	Baseline
Primary	Recovery Capital	Measured by Assessment of Recovery Capital (ARC)	3-months
Primary	Recovery Capital	Measured by Assessment of Recovery Capital (ARC)	6-months
Primary	Recovery Capital	Measured by Assessment of Recovery Capital (ARC)	9-months
Primary	Alcohol or other drug 12-Step Participation	Measured by self-report using the Alcoholics Anonymous Inventory (AAI)	Baseline
Primary	Alcohol or other drug 12-Step Participation	Measured by self-report using the Alcoholics Anonymous Inventory (AAI)	3-months
Primary	Alcohol or other drug 12-Step Participation	Measured by self-report using the Alcoholics Anonymous Inventory (AAI)	6-months
Primary	Alcohol or other drug 12-Step Participation	Measured by self-report using the Alcoholics Anonymous Inventory (AAI)	9-months
Primary	Overdose Risk	Self-report using the Overdose Risk Questionnaire (OdRi)	Baseline
Primary	Overdose Risk	Self-report using the Overdose Risk Questionnaire (OdRi)	3-months
Primary	Overdose Risk	Self-report using the Overdose Risk Questionnaire (OdRi)	6-months
Primary	Overdose Risk	Self-report using the Overdose Risk Questionnaire (OdRi)	9-months
Primary	Number of Outreach and Linkage Sessions	Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet	Baseline
Primary	Number of Outreach and Linkage Sessions	Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet	3-months
Primary	Number of Outreach and Linkage Sessions	Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet	6-months
Primary	Number of Outreach and Linkage Sessions	Self-reported using the Psychosocial Treatment & Healthcare Services Tracking Sheet	9-months
Primary	Baseline Demographics	Self-reported using the Addiction Severity Index (ASI)	Baseline
Primary	Suicide Severity	Self-report using the Columbia-Suicide Severity Rating Scale (C-SSRS)	Screening
Primary	Community Health & Social Needs	Self-report using the Accountable Health Communities & Health-Related Social Needs	Baseline
Primary	Fidelity to Intervention	Measured via clinical staff submitting weekly treatment fidelity logs	Weekly
Primary	Acceptability & Appropriateness	Using the The Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM)	6-months
Primary	Feasibility of Intervention	Using the Feasibility of Intervention Measure (FIM)	6-months
Primary	Satisfaction with Care	Self-report using the Treatment Satisfaction Questionnaire	6-months